Position: RWE Associate Project Manager
Report to: RWE Sr. Project Manger
DUTIES & RESPONSIBILITIES
1. Working within a highly qualified team leader you will coordinate Partner and CRO to fulfil project and maintain project timeline.
2. Establish and monitor project budgets and expenditure.
3. Working independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation
4. Ensure adherence to protocol and other guidelines and requirements relevents to the project.
5. Managing interfaces with other groups and vendors to support supplies management, laboratories, quality control etc.
6. Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested
7. Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required
8. Managing data manager generated queries efficiently and responsible for study cost effectiveness
9. Dependent on level of experience you may assist in training and mentoring less experienced CRA’s and/or manage CRA’s working on projects
10. Accompany visit and Quality control visit for site, on-site inspection support
11. Oversight outsourced project CRO or CRA work
12. Maintain good relationship with KOL and GCP officer.
KNOWLEDGE AND COMPETENCIES
1. 3-4 years+ of monitoring experience in phase I~IV trials as a CRA, experience in RWS is preferred
2. Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data
3. Native Chinese level and conversational English at least
4. Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner
5. Ability to produce accurate work to tight deadlines within a pressurized environment